BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIGHTSHEER ( ALL MODELS)

    MDR report key: 2973803 · Received August 7, 2007

    Report

    Report Number
    2914019-2007-00024
    Event Type
    Other
    Date Received
    August 7, 2007
    Date of Event
    July 2, 2007
    Report Date
    August 7, 2007
    Manufacturer
    LUMENIS, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER SERVICE TECH, REGULATORY INSPECTION NOTED DIRTY TOUCHSCREEN AND ENERGY METER GLASS. HANDPIECE TIP DIRTY AND LOOKS CLOUDED. PERFORMED INITIAL FINAL AND CONFIRM ENERGY OUTPUT. FIRED AT 37J WHICH WAS AT 40MS. THE DISPLAY GASKET WAS DISLOCATED AND DIRTY, REPLACED THE GASKET. THE ENERGY METER GLASS HAD THICK COATING OF SUBSTANCE. CLEANED TOUCHSCREEN, ENERGY METER GLASS, AND CLEAN TIP. PERFORMED ENERGY METER CALIBRATION. PERFORMED NECESSARY RELIABILITY IMPROVEMENTS AND FINAL TEST. ROOT CAUSE TOUCHSCREEN AND METER GLASS DIRTY.

    Description of Event or Problem · 1

    ONE PATIENT HAS BEEN BURNED, NAME IS (B)(6) AND I AM THE AESTHETIC NURSE. THE PROCEDURE WAS LASER HAIR REMOVAL OF UNDERARMS, BIKINI, AND FULL LEG WITH THE LUMENIS LIGHTSHEER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSHEER ( ALL MODELS) OTHER GEX LUMENIS, INC. LIGHTSHEER NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other